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BP Med Recalled


July 11, 2016

More than 25,000 bottles of lisinopril tablets are being recalled nationwide by Lupin Pharmaceuticals.

What’s the reason? Deviations in manufacturing practices prompted the recall as active pharmaceutical ingredients were used whose intermediates failed specifications, according to the US Food and Drug Administration’s Enforcement Report.

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Which lots are included in the Class III recall?

 

Presentation

Lot

Expiration

30 mg

H303487

September 2016

30 mg

H303488

September 2016

30 mg

H303489

September 2016

40 mg

H303449

September 2016

 

The drugs were manufactured in India.

This is not the first time products made by Lupin have raised concern. In 2015, manufacturing practices at one of its plants that makes oral contraceptives received a Form 483 from the FDA.

Click here to read the report.

 

--Stephanie Vaccaro

 

Reference:

US Food and Drug Administration. FDA Enforcement Report – Week of July 6, 2016. www.fda.gov. Accessed July 11, 2016.

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